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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00895219
Other study ID # 06/Q0404/64
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received May 7, 2009
Last updated May 7, 2009
Start date July 2007
Est. completion date December 2009

Study information

Verified date April 2009
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

Traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. There is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over time. When treatment includes breathing techniques only it is difficult for a person with chronic hyperventilation, who has developed muscle and connective tissue changes, to revert to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when the problems which have developed in the musculoskeletal system are addressed, the patient reverts more quickly to the lower chest pattern of breathing but there is as yet little evidence to support this clinical finding.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- diagnosis of dysfunctional breathing (Nijmegen score of more than 23)

Exclusion Criteria:

- active metastatic disease

- osteoporotic disease

- dysfunctional breathing as a consequence of respiratory or cardiac disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Breathing re-training
Breathing re-training
Breathing re-training and musculoskeletal techniques
Breathing re-training and musculoskeletal physiotherapy techniques including mobilisation techniques to normalise muscle and joint restrictions, doming of the diaphragm to enhance contraction and relaxation, and rib raising to free restriction in rib cage motion.

Locations

Country Name City State
United Kingdom Royal Brompton Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nijmegen Questionnaire 0, 2, 4, 8, 12 and 26 weeks No
Secondary Six-minute walking test 0, 2, 4, 8, 12 & 26 weeks No
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